CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
- Conditions
- Cluster Headache
- Interventions
- Drug: Placebo
- Registration Number
- NCT02466334
- Lead Sponsor
- Danish Headache Center
- Brief Summary
It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.
The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.
Based on the above the investigators hypothesize the following:
1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks
2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Fulfillment of IHS criteria for cluster headache either chronic or episodic
- Patients in bouts 1-32 attacks per week
- Patients in remission minimum of 1 month remission time
- fertile women must use safe contraception
- All other primary types of headache
- headache 8 hours or less before study day begins
- pregnant or lactating women
- any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active Calcitonin-Gene Related Peptide 1.5µg/min IV calcitonin-gene related peptide for 20 minutes Placebo Placebo IV placebo for 20 minutes
- Primary Outcome Measures
Name Time Method Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups 90 min after administration of study drug Occurence of experimentally induced cluster headache attack yes/no
AUC headache on CGRP day compared to placebo day in all three groups 90 min after administration of study drug Using 90 min headache questionnaire
Time to maximum headache score on CGRP day compared to placebo day in all three 90 min after administration of study drug Using 90 min headache questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Danish Headache Center
🇩🇰Copenhagen, Glostrup, Denmark